Gulf War 1990–91: Vaccines

Lord Morris of Manchester: asked Her Majesty's Government:
	Whether they are now able to respond in full to the Written Question tabled by the Lord Morris of Manchester on 22 January (HL 1248) on the vaccines used during the 1990–91 Gulf War.

Lord Bach: I wrote to you on 9 October, and the full text of my letter is as follows:
	"Further to my letter of 17 September (reference: D/MIN(DP)/WB PQ 1280N), I am writing in answer to your Parliamentary Question of 4 February (Official Report, Col. WA 26) about the medical countermeasures used to protect our personnel during the 1990–91 Gulf Conflict. Again, I would like to say how sorry I am that you have had to wait for so long for me to do so.
	You asked about the anthrax vaccine personnel received in 1991. At Annex A, I have set out a detailed history of our use of the vaccine, the guidance accompanying its use and how this has evolved. As you will see, anthrax vaccine has been licensed in the UK since 1979. The statement referred to by Lord Hunt (Official Report, 20 January 2003, WA 79, that the anthrax "vaccine should be used alone") was not in place in 1991 and was not included in the anthrax vaccine product licence until 1998. The anthrax vaccine patient information leaflet (PIL) was not introduced until April 1999.
	You also asked whether any other vaccines administered in 1990–91 were to be "used alone". The table at Annex B lists the main vaccines offered for the 1990–91 Gulf conflict and summarises the information currently available regarding co-administration. Furthermore, at the time of the conflict, a joint service publication provided guidance to service medical staff on vaccinations, including the need to ensure that the individual to be vaccinated was not undergoing radiotherapy or treatment with corticosteroids and that the appropriate time interval after any previous immunisation had elapsed.
	As you know, personal medical records (F Med 4) were generally not taken to the Gulf during the 1990–91 conflict, and were therefore unavailable for the recording of vaccination details. However, the names of those who received vaccinations should have been recorded on temporary nominal rolls compiled in theatre. Whenever possible, details should also have been recorded on form B Med 27, but many personnel who deployed to the Gulf did not carry these documents. The details recorded on nominal rolls and B Med 27s should have been transcribed onto F Med 4s on return from the Gulf. In many cases this did not happen, and the vaccination records of many Gulf veterans are incomplete as a result. Estimates of the precise extent to which vaccination schedules were complied with in practice, therefore, are not readily available. Similarly, the extent to which Defence Medical Services staff discussed with patients issues such as what other medication individuals were receiving is not readily available.
	The nerve agent pre-treatment sets (NAPS) tablets designed to protect troops in the event of exposure to chemical warfare agents each contained pyridostigmine bromide. The instructions for taking NAPS tablets were not subject to a restriction on co-administration and never have been.
	In my Written Answer to Lord Clement-Jones (Official Report, 7 March 2003, Col. WA 134), I undertook to publish this letter to you in the Official Report. This was confirmed in my letter to you of 25 March (reference: D/MIN(DP)/WB 1105/03/C) and is in hand. I have also arranged for a copy of this letter to be placed in the Library of the House and one to be sent to Lord Clement-Jones." Annex A Administration of Anthrax Vaccine offered to UK Military Personnel—1990 to 2003 Background 1. Anthrax is an infectious disease that can kill. It has a number of characteristics that make it an obvious choice as a biological weapon (BW). The best single way to protect against many diseases is via immunisation but no vaccine guarantees absolute protection. An anthrax vaccine has been produced in the UK by the Centre for Applied Microbiology and Research (CAMR) 1 since 1956. It has been used routinely to protect those at risk from anthrax since 1963 and has been licensed in the UK since 26 November 1979. Many thousands of people, including laboratory workers, veterinary surgeons, abattoir workers and military personnel, have been immunised. The anthrax vaccine used in the UK is a sterile product made from a type of anthrax that does not cause the disease. It does not contain any anthrax bacteria and it is therefore impossible to contract anthrax from the vaccine. August 1990 2. When Iraq invaded Kuwait in August 1990, an international coalition was formed to which the UK contributed Armed Forces, initially to prevent any further Iraqi aggression and subsequently to liberate Kuwait. The UK military threat assessment was that Iraq had a BW capability that included the ability to use anthrax as a weapon. It was therefore necessary for the Ministry of Defence (MoD) to provide the best available protection for its personnel deploying to the region.
	1 CAMR's predecessor was the Microbiological Research Establishment. CAMR is now a component part of the Health Protection Agency which is a new Special Health Authority, established on 1 April 2003. 3. Based on studies 2 by the CAMR, MoD believed co-administration of pertussis (whooping cough) vaccine 3 offered a way of increasing the protection provided by the anthrax vaccine in the short time available between administering the vaccine and the expected start of hostilities. In 1990, a UK licensed 4 pertussis vaccine was produced by Wellcome Research Laboratories. The vaccine was not however recommended for use in adults and it was not licensed for use as an adjuvant 5 to anthrax vaccine. There were competing demands on this source of pertussis vaccine and MoD's full requirement could not be met by Wellcome. A French manufacturer, Institut Merieux (now Aventis Pasteur MSD), was identified which had sufficient stock available. November–December 1990 4. In November 1990, MoD placed an order, through the Procurement Unit of the Department of Health (DH), for 40,000 doses 6 of Institut Merieux pertussis vaccine. This vaccine was not licensed for use in the UK but was in France as Vaxicoq. At the recommendation of the DH, the UK's National Institute for Biological Standards and Control (NIBSC) 7 carried out toxicity tests on the imported pertussis vaccine and reported that the test results showed the batches to be within specifications according to procedures used at NIBSC as specified in the release criteria of the Product Licence for paediatric vaccine. 5. In late 1990, the NIBSC also tested the effects of administering anthrax alone, pertussis alone and both vaccines simultaneously in mice 8 and in guinea pigs 9 . Staff at NIBSC had not been asked by MoD to undertake this work, but had deduced that MoD was planning to use pertussis as an adjuvant and therefore decided that a check for interactions might be helpful. 6. The initial screening test experiment undertaken at NIBSC used 1 standard human dose (SHD) of vaccines. In a mouse, a SHD of vaccine equates to approximately 160 times the human(10) equivalent on the basis of body weight.
	2 Turnbull et al, "Protection conferred by microbiologically-supplemented UK and purified PA vaccines", Proceedings of the International Workshop on Anthrax, Winchester, April 11–13 1989: pp89–91. Salisbury Medical Bulletin, Special Supplement, No. 68.
	3 Pertussis vaccine is a suspension of killed Bordetella pertussis organisms.
	4 Product Licence 0003/5138.
	5 An adjuvant is a substance used to accelerate enhance or prolong a specific immune response.
	6 This order quantity was later increased.
	7 NIBSC is the UK's Official Medicines Control Laboratory for biological medicines.
	8 Balb/c mice.
	9 Harley guinea pigs (Olac).
	(10) Pertussis given to infants from 2 months of age. Average male infant at age 2 months = 4kg, laboratory mouse = 25gms. 7. The findings, based on 1 SHD which the NIBSC described as "preliminary", caused concern to the Institute because there was evidence of severe loss of condition and weight loss in mice when anthrax and pertussis vaccines were given together. This did not occur when these vaccines were given separately. The simultaneous test in guinea pigs showed no obvious reaction in the animals. The NIBSC alerted the DH to its concerns on 21 December 1990 and faxed a letter to the DH. The NIBSC letter was then faxed to the MoD by the DH under cover of a manuscript note written by Dr Jeremy Metters, the then Deputy Chief Medical Officer, and dated 21 December 1990. Dr Metters recalls advising MoD of the importance and relevance of the information from NIBSC and of their and his concerns. 8. The text of the NIBSC letter and that of the DH fax was made public in a paper published by MoD in October 1997(11). That paper reported that the NIBSC official involved believed he had discussed the matter with two, possibly three, MoD officials (not the recipient of the DH fax). As the October 1997 paper made clear, there is no material on the MoD departmental record which shows whether the NIBSC's research findings were taken into account by MoD when formulating the policy on the use of pertussis vaccine, although the general issue of possible side effects was addressed in guidance concerning the MoD's anti-BW immunisation programme. 2 January 1991—End March 1991 9. MoD's anti-BW immunisation programme, which included co-administration of anthrax and pertussis vaccine, began on 2 January 1991 and ended on about 20 March 1991. The vaccines were to be co-administered at an initial date, then at three weeks and a third dose given at seven weeks. On each occasion, a 0.5ml anthrax vaccine intramuscular dose was to be administered by injection into the deltoid muscle, accompanied by an intramuscular injection into an adjacent site on the same deltoid muscle of 0.5ml of pertussis vaccine. The prescribed primary dosing schedule in 1991, as now, involves four doses of vaccine—a first injection, a second three weeks after the first, a third three weeks after the second and a fourth six months after the third. Using this protracted thirty-two week immunisation schedule would have risked leaving personnel unprotected during the 1990–91 Gulf conflict, hence the requirement to devise ways of inducing immunity to anthrax more rapidly. A paper(12) published by the MoD in January 2000 sets out further information on how the anti-BW immunisation programme was implemented.
	(11) MoD paper: Background to the Use of Medical Countermeasures to Protect British Forces during the Gulf War (Operation GRANBY) dated October 1997. See: http://www.mod.uk/issues/gulfwar/info/medical/mcm/htm
	(12) MoD paper: Implementation Of The Immunisation Programme Against Biological Warfare Agents For UK Forces During the Gulf Conflict 1990–1991 dated 20 January 2000. See: http://www.mod.uk/issues/gulfwar/info/medical/bwa/ch1.htm 10. The anthrax vaccine manufactured by CAMR and administered to personnel was supplied under UK marketing authorisation product licence (PL) number 01511/0037. The vaccine was supplied in single dose 0.5ml ampoules, each packed in cardboard box. An advice leaflet data sheet entitled: "For the Medical and Pharmaceutical Professions" was supplied in each box containing a vaccine ampoule. The advice leaflet was reproduced as Annex A to the MoD paper published in October 1997 referred to above. It did not stipulate that the anthrax vaccine should be given alone. The advice leaflet said that three 0.5ml immunisation doses should be given intramuscularly at intervals of three weeks, followed by a fourth dose at an interval of six months, with reinforcing doses (0.5ml) given intramuscularly annually. Early 1998 11. In early 1998, a stock of shelf life expired anthrax vaccine was held at CAMR. Because MoD had requested further supplies of anthrax vaccine, (see paragraph 18 below), CAMR sought to extend the shelf life of these stocks. On 3 February 1998, following a request from CAMR, the NIBSC wrote to the Medicines Control Agency (MCA) as follows:
	"We now have the re-test results from CAMR and also have completed our own toxicity tests. The results of toxicity testing are satisfactory and show no evidence of any increase in acute specific or general toxicity. The tests used provide no information on long term toxicity, however. There is evidence of some decline in potency as reflected by the protective activity in guinea-pigs. Nevertheless the vaccine still retains protective activity although it is not possible to estimate how this would relate to the response in human subjects. No studies were done on the effect of co-administering the vaccine with other preparations and such a practice cannot be recommended.
	Taking these observations into account, these vaccine batches appear to be within specification although it should be noted that experience with product of this age is very limited. I would not recommend extension of shelf life beyond November 1998." 12. This precautionary advice to the MCA was given in the light of the NIBSC work on simultaneous administration of anthrax and pertussis vaccines undertaken in late 1990. Account was taken too of the age of the vaccine which had been manufactured in 1991. 13. The next day—4 February 1998—the MCA issued an approval letter to the DH for a variation to PL 01511/0037, extending the shelf-life for anthrax vaccine batches 348/E, 349/E, 350/E and 351/E to the end of November 1998, and stated in their variation letter to DH: "The vaccine to be used alone. There is no evidence for safe use in combination with other vaccines or medicinal products" which is a little clearer than the NIBSC letter. The NIBSC letter was copied to CAMR and DH. At some point on or before 17 February 1998, the MCA letter was also copied to CAMR. 16 February 1998 14. On 16 February 1998, the MoD's Advisory Group on Medical Countermeasures (AGMC)(13) met. The AGMC considered contraindications to the use of anthrax vaccine and whether MoD should use an adjuvant, as it had done in 1991. It appears from the minutes of the meeting that Dr Metters (who attended) was aware of the MCA variation. He now does not recall any disagreement about the restriction on co-administration MCA had imposed. Unfortunately, this issue is not covered in the minutes of the meeting. What the minutes do record is that: ". . . the Group was not aware of any risk associated with interactions with other vaccines; these would likely be local rather than ill-health manifestations." In any case, the AGMC did not recommend the use of an adjuvant on this occasion. MoD Ministers subsequently accepted the recommendation of the AGMC that UK forces due to deploy should again be offered immunisation against anthrax, with no adjuvant. 17 February 1998 15. On 17 February 1998, following discussion with a member of staff at the MoD's Medical Supplies Agency (MSA)(14), the Head of Regulatory Affairs at CAMR faxed the NIBSC letter of 3 February 1998 and the MCA letter of 4 February 1998 to MSA. The main purpose of the fax was to notify the MSA that the MCA had granted a shelf life extension to anthrax vaccine batches 348/E, 349/E, 350/E and 351/E held at CAMR. 16. The anthrax vaccine that had its shelf life extended was still packaged with the original "For the Medical and Pharmaceutical Professions" leaflet at CAMR. At that time, the MCA were in the middle of a phased implementation of the Patient Pack Initiative (PPI). The aim of the PPI was to create for all licensed products two documents: a summary of product characteristics (SPC) and a patient information leaflet (PIL). The SPC is part of the product licence and provides information on the indications for treatment, contra-indications, dose and administration, warnings and precautions, adverse drug reactions, and pharmaceutical characteristics of the drug. When new drug safety information becomes available, SPCs are routinely updated to include this information. PILs contain similar information to SPCs but are written specifically for patients. PILs are also updated routinely. 17. In 1998, it was agreed between the MCA and CAMR that the anthrax batches to be supplied to MoD (MSA) would be over-labelled only, with the new expiry date. It was agreed there would be no re-write of the advice leaflet in the SPC/PIL format. This was because the MCA allowed a period of up to six months for manufacturers to introduce new leaflets
	(13) The AGMC is a non-Departmental public body affiliated to the MoD and made up of leading medical and medical ethics specialists.
	(14) The MSA is a supply agency, not a medical licensing or regulatory body. and there was no indication from the MCA that this was an urgent safety need. Furthermore, CAMR had agreed with DH a deferral to delay participation in the PPI until the next licence renewal and the next anthrax licence renewal (PL 1511/0058) submission was due in September 1998. The then current licence was only extended until 30 November 1998, in line with the shelf life extension of the four vaccine batches identified earlier. Consequentially the DH supplied the labelling proofs to MCA for approval on 5 February 1998 and MCA approved this labelling by return on the same day due to the need to supply vaccine to the MoD without delay. todd March 1998 18. In March 1998, UK forces were once again to be deployed (Operation BOLTON) in the Gulf region following Iraq's decision not to co-operate with the United Nations Special Commission for Iraq (UNSCOM.) The assessed threat of attack from Iraqi BW had been reduced, but not eliminated, by the activities of the UNSCOM. The need to again protect UK forces was vital. 19. On 3 March 1998, MoD announced(15) that a voluntary immunisation programme (VIP) against anthrax would begin later that month. The announcement made clear that "no other vaccine will be co-administered with the anthrax vaccine . . ." A letter from the then Secretary of State for Defence, addressed to all UK Service personnel and civilians in the Gulf region, stated that ". . . administering it on its own avoids any possibility of side-effects caused by interaction with another vaccine used as an adjuvant." The vaccine was to be administered in a four-dose schedule (at an initial date, at three weeks, at six weeks and at thirty-two weeks to be followed by an annual booster) and this was explained in the various guidance issued to commanders, medical officers and personnel receiving the vaccine. November 1998 20. The VIP against anthrax had to be suspended in November 1998 because of a shortage of MoD stocks due to anthrax vaccine manufacturing problems at the CAMR. December 1998—early 1999 21. In December 1998, there were still anthrax vaccine manufacturing problems at the CAMR. CAMR could not manufacture new batches of anthrax vaccine until the facility had been upgraded. The supply position was discussed at Anthrax Vaccine Production Working Group(16) (AVPWG) meetings. On the basis that anthrax batches 348/E, 349/E, 350/E and 351/E had undergone prior shelf life extensions earlier in the year and that the standard had retained potency, it was suggested that the batches be put forward for further shelf life extension following re-testing and submission to the MCA. Following the re-test results and NIBSC approval, CAMR requested DH to submit a variation application to MCA for a shelf life extension.
	(15) HoL, Official Report, 3 March 1998, Column WA154; HoC,. Official Report, 3 March 1998, Column 535.
	(16) AVPWG, Chaired by the DH with representatives from CAMR, NIBSC, MSA, DH, MCA/MHRA and MoD. 22. On 16 December 1998, the MCA received a request to grant a further shelf-life extension to anthrax vaccine Batch 351/E. The MCA granted a variation to PL 01511/0037, extending the shelf-life of this batch of vaccine to 31 January 2000. At this point (16 January 1999), the MCA requested DH, as the licence holder, to add the following additional warnings to the SPC and PIL: "The vaccine should be used alone. There is no evidence for the safe use in combination with other vaccines or medicinal products. The vaccine contains thiomersal and therefore it is possible that delayed hypersensitivity and sensitisation reactions may occur". The approval date for this variation was 15 January 1999. The revised SPC and PIL information was to apply to the anthrax vaccine batches not used and manufactured under PL 01511/0037 and future stocks to be manufactured under PL 01511/0058. 23. The changes in the wording of PL 01511/0037 were conveyed to the manufacturer, CAMR. The SPC and PIL were approved on 4 March 1999. The packaging was changed and new SPC and PIL documents were inserted with doses of the vaccine. This was the first time (April 1999) that the SPC included the statement that the vaccine should be "used alone". The reason for the gap between the decision in 1998 and the introduction of the SPC/PIL was that this was the first time a new format SPC and PIL was issued and there was much consultation between all involved. These changes took place while the MoD's VIP against anthrax was suspended. March 2001 24. In March 2001, newly manufactured anthrax vaccine from CAMR became available for use under PL 01511/0058, the vaccine having passed release tests at NIBSC. May 2001—Resumption of the VIP against Anthrax 25. MoD resumed its VIP against anthrax in May 2001 as new stock had become available. The resumption of the VIP against anthrax was accompanied by a MoD Surgeon General's policy letter (SGPL)(17) dated 21 May 2001. SGPL's are sent to all medical practitioners in the Defence Medical Services. This letter stated: "All personnel who wish to accept the vaccine are to be immunised in accordance with the Department of Health (DH) Anthrax Vaccine Datasheet and the DH Anthrax Patient Information Leaflet." These documents were reproduced as Enclosures 1 and 2 respectively to the SGPL. Enclosure 1 included the instruction: "The vaccine should be used alone." 26. The SGPL contained information on the timing of anthrax immunisations. The SGPL explained that the vaccine should be given in four doses—initial dose, at three, six and thirty-two weeks, and gave additional guidance on immunisation schedules for those personnel who had already received one or more doses from before the programme was suspended.
	(17) D/SG(Plans)923/2/8/1 dated 21 May 2001. June 2002—Expansion of the MoD's Voluntary Immunisation Programme against Anthrax 27. In June 2002, the MoD announced(18) that its VIP against anthrax would be expanded, in phases, to the whole of the Armed Forces, including reserves and to those essential civilians who were likely to deploy on operations, beginning with those in units that were held at the highest readiness. As in May 2001, this decision was promulgated by a SGPL(19). This SGPL cancelled the earlier SGPL, repeated the SPC and PIL text and gave further guidance as follows:
	"Ideally, anthrax vaccine should be given separately from other immunisations. However, there may be situations when several immunisations have to be administered together for expediency. If this situation occurs, then the anthrax vaccine may be given at the same time as other vaccines so long as a separate injection site is used (ideally the opposite arm). Notwithstanding, the anthrax vaccine is not recommended to be administered at the same time as a live vaccine or gamma globulin (although this is little used now) and at least five days should elapse between such immunisations. Anthrax vaccine is a sub-component vaccine and so should not interfere with the efficacy of other vaccines or interact with them . . ." 28. This additional guidance, developed for MoD by the AGMC was designed to clarify the "should be used alone" statement in the SPC. 29. The advice contained in the 13 June 2002 SGPL repeated that of the 21 May 2001 SGPL regarding the timing of immunisations as set out above. 2003—The Lord Morris of Manchester's Parliamentary Question 30. On 22 January 2003, the Lord Morris of Manchester tabled a Parliamentary Question (PQ)(20), which asked, inter alia, about the position on anthrax vaccine licensing in 1990–91. This PQ prompted the MCA to ask the Committee on Safety of Medicines (CSM) to review the licensing information on the administration of anthrax vaccine. The Vaccine Sub-Group of the CSM met on 10 February 2003 and recommended that the restriction on co-administration promulgated in 1999 be removed. This recommendation was endorsed by the CSM on 12 February 2003. 31. The then Secretary of State for Health asked the CSM to reconvene to further consider this issue to ensure that the committee had taken account of all available scientific data (including the original 1990 NIBSC animal studies). On 4 March 2003, a specially convened anthrax expert sub-group of the CSM met to review all available evidence on the safety of anthrax vaccine. On 12 March 2003, the CSM reconsidered the advice it had given earlier in the light of the recommendations of the expert sub-group, and
	(18) Official Report, HoL, 13 June 2002, Column WA 46; Official Report, HoC, 13 June 2002, Column 1345W.
	(19) D/SG(Plans)923/2/8/1 dated 13 June 2002.
	(20) HoL, Official Report, 4 February 2003, Column WA 26. concluded that none of the human and animal data available to Members of the committee in respect of UK and US anthrax vaccines warranted the advice that the vaccine should be used alone. The CSM's conclusion differed to that reached by NIBSC and MCA in 1998 because the precautionary approach adopted in 1998 was based on the fact that the anthrax vaccine batches whose shelf-life was being extended was old and because of the results of the 1990 mouse-based work on anthrax and pertussis administration. But by 2003, new studies had been undertaken in which the 1990 results could not be replicated. In addition, there was also no suggestion that anthrax was to be used in combination with pertussis vaccine. 32. The CSM therefore recommended changes to the anthrax PL to read as follows, with the statement: "The vaccine should be used alone" to be deleted from the SPC:
	Anthrax vaccine must not be mixed with any other vaccine or other medicinal product in the same syringe.
	If necessary, anthrax vaccine may be given at the same time as other vaccines. Other injectable vaccines should be administered by separate injections into different anatomical sites and, ideally, into different limbs.
	Subjects who are receiving immuno-suppressive therapy, including high dose corticosteroids, may be given anthrax vaccine but may not mount an adequate immune response. 33. The Licensing Authority (the MCA, now part of the Medicines and Healthcare Products Regulatory Agency) approved this variation on 16 April 2003. The anthrax vaccine PL will be amended accordingly and a revised SGPL will then be issued. 34. Further information about MoD's current VIP against anthrax can be found on the Internet at: http://www.mod.uk/issues/anthrax/index.htm. Annex B Immunisations Offered for the 1990–91 Gulf Conflict (Operation Granby)
	
		
			 Immunisation (Notes 1, 2 & 3) Position in 1990–91 
			 Anthrax Offered to all personnel deploying. To be co-administered with pertussis vaccine. No advice given in the leaflet accompanying the anthrax vaccine for medical and pharmaceutical professions about the need to avoid co-administration. Nothing on contra-indications. 
			 Cholera Offered to all personnel deploying. Not to be administered to a subject who has experienced a serious reaction (e.g. anaphylaxis) to a previous dose of this vaccine or who is known to be hypersensitive to any component thereof. Advisable to avoid vaccination during acute infection, or chronic illness. 
			 Diptheria Offered to all non-immune personnel. 
			 Gamma Globulin Made up of human normal immunoglobulin (HNIG). Certain occupational groups, such as those handling food and water supplies, may have been offered a Gamma Globulin immunisation. Must not be administered intravenously. HNIG is for use as a single entry dose only: unused proportions should be discarded. HNIG is not suitable for modifying reactions to measles vaccine. HNIG will not affect the immune response to bacterial vaccines but could reduce the response to some virus vaccines and toxoids. At least 4 weeks should elapse after the last dose of the following vaccines before HNIG is administered: Polio (live or inactivated), Measles, Rubella, Diptheria or Tetanus. (This warning does not apply to Yellow Fever vaccine as HNIG does not contain antibody to this virus). 
			  MoD is aware of one individual who was part of a medical unit that served in Operation GRANBY who is recorded as having received Gamma Globulin. 
			 Hepatitis B Offered to medical personnel. Position on contra-indications not available. 
			 Meningococcal meningitis Vaccine must not be given to those who have previously experienced a serious reaction to the vaccine or its components. Vaccination should be delayed if an acute infection is present. 
			  In August 1990, immunisation against meningococcal meningitis strains A and C was recommended for all personnel serving in the Gulf. By 15 September 1990, the immunisation was no longer recommended except for medical personnel and personnel who may be at risk by way of frequent contact with host nation personnel. Immunisation against meningococcal meningitis strains A and C involved one vaccination which was effective against both strains. 
			 Pertussis Offered as adjuvant to all personnel deploying. The contra-indications relating to the UK sourced vaccine only relate to administration to children. The datasheet for the vaccine manufactured in France says: "Those of all vaccinations. The practicing physician remains the sole judge of the advisability of vaccination." 
			 Plague Offered to all personnel deploying. The manufacturers product safety leaflet said that "Plague Vaccine should not be administered to anyone with a known hypersensitivity to any of the produce constituents, such as beef protein, soya, casein, phenol, and formaldehyde. Patients who have had severe local or systematic reactions to plague vaccine injections should not be revaccinated. Plague vaccine should not be administered to patients who have severe thrombocytopenia or any coagulation disorder that would contraindicate intramuscular injections." 
			 Poliomyelitis Offered to all non-immune personnel. Administered by mouth. Contraindications: The vaccine should not be used in the presence of acute febrile illness or inter-current infection, diarrhoea, vomiting or other gastrointestinal disturbance, neither should it be given in the presence of impaired immune response including leukaemia, lymphoma, generalized malignancy or treatment with corticosteroids, cytotoxic drugs or irradiation. Do not give to those known to be hypersensitive to neomycin. 
			  Interactions with other medicaments and other forms of interaction: At least 3 weeks should normally intervene between the administration of any two live vaccines. Poliomyelitis vaccines can, however, be given simultaneously with measles, mumps and rubella vaccines. In this case the injectable vaccines should be given at different sites 
			  Effects on ability to drive and to use machines: Not applicable. 
			  Other undesirable effects (frequency and seriousness): Paralysis temporally associated with vaccination has been reported very rarely in recipients or contacts. 
			  Use in pregnancy and lactation: Pregnant women should not be given oral poliomyelitis vaccine unless they are at definite risk from poliomyelitis. 
			  Other special warnings and precautions: The vaccine may contain trace amounts of penicillin and streptomycin which should not contra-indicate its use except in those with a history of severe anaphylaxis due to either antibiotic. 
			  Overdose (symptoms, emergency procedures, antidotes): Not applicable. 
			  Incompatibilities: none. 
			 Tetanus Offered to all personnel, administered with typhoid vaccine as one combined immunisation. Absorbed Tetanus vaccine should not be administered intradermally. The vaccine should not be administered to a subject who has experienced a serious reaction (e.g. anaphylaxis) to a previous dose of this vaccine or who is known to be hypersensitive to any component thereof. It is advisable to avoid vaccination during an acute infection. 
			 Tuberculosis Recruits without a BCG immunisation scar and who were not shown to be immune were offered BCG immunisation. It was not to be given if the subject was receiving treatment with corticosteroids or other immuno-suppressive treatment, including general radiation. No further immunisation should be given for at least three months in the arm used for BCG immunisation because of the risk of regional infection of the lymph nodes (glands) and lymph channels. 
			 Typhoid Offered to all personnel. Administered with tetanus vaccine as one combined immunisation. The vaccine should not be administered to a subject who has experienced a serious reaction (e.g. anaphylaxis) to a previous dose of this vaccine or who is known to be hypersensitive to any component thereof. It is advisable to avoid vaccination during an acute infection. 
			 Yellow Fever Offered routinely to servicemen. Servicewomen were only to be immunised if they were travelling to a region where yellow fever was endemic. However, MoD is aware of records for servicewomen who served with a unit that deployed to the Gulf as routinely receiving Yellow Fever immunisation. 
			  The datasheet said: The vaccine should not be administered to a subject who has experienced a serious reaction (e.g. anaphylaxis) to a previous dose of this vaccine or who is known to be hypersensitive to any component thereof. It is advisable to avoid vaccination during an acute infection. Since the vaccine is prepared in chick embryos and contains small quantities of neomycin and polymyxin it should not be administered to individuals who are hypersensitive to egg or chick protein or to these antibiotics. The vaccine should not be given to those with impaired immune responsiveness, whether idiopathic or as a result of treatment with steroids, radiotherapy cytotoxic drugs or other agents. 
		
	
	Note:
	1. Vaccines listed in alphabetical order for ease of reference.
	2. Other immunisations may have been offered on the basis of clinical need.
	3. Summary of product characteristics (SPC) and patient information leaflets (PIL) were not introduced for UK licensed vaccines until after the 1990–91 Gulf conflict.

National Memorial Arboretum

Baroness Lockwood: asked Her Majesty's Government:
	What proposals the Government have to provide support to the National Memorial Arboretum in Alrewas, Staffordshire.

Lord Bach: We are pleased to advise this House that the Government have decided to make a grant-in-aid of £250,000 a year for an initial period of three years to the National Memorial Arboretum Company Limited towards the running costs of the National Memorial Arboretum at Alrewas, Staffordshire. This will be subject to the Ministry of Defence and the National Memorial Arboretum Company Limited signing a management statement and financial memorandum which define the terms under which the grant-in-aid will be managed.

Hull

Lord Laird: asked Her Majesty's Government:
	What support they are giving or plan to give to the local authorities in the Hull area to help with the improvement of quality of life there.

Lord Rooker: The Government are providing support to local authorities in the Hull area in a number of key areas. On housing, major repairs allowance for the maintenance of council housing of over £16.5 million has been provided for 2003–04 in Hull. On neighbourhood renewal, NRF funding for Hull between 2001 and 2006 amounts to £31.8 million.
	In April 2000 the Government granted £55 million over a 10-year period to the Preston Road NDC (New Deal for Communities) programme. The programme aims to deliver economic prosperity, safer communities, high quality education, decent housing and better health to the area and is contributing to the quality of life for residents in East Hull.
	More generally the Government are working closely with Kingston-upon-Hull City Council, through an appointed lead official, to support improvement in the performance of the council and in the services it provides.

NHS: Private Patient Charging

Baroness Noakes: asked Her Majesty's Government:
	Whether National Health Service trusts are permitted to use marginal costing in arriving at charges made to private patients.

Lord Warner: National Health Service trusts should not cross-subsidise private sector work from the NHS.

Older People: Mortality Rates and Weather Conditions

Lord Morris of Manchester: asked Her Majesty's Government:
	What estimate they have made of the higher prevalence of deaths among older vulnerable people during this year's exceptionally high summer temperatures; and what action they are taking in response to these deaths.

Lord Warner: The Office for National Statistics routinely publishes weekly estimates of deaths registered in England and Wales. These indicated 907 more deaths registered in the week ending 15 August, which included the day on which the hottest temperature was recorded. During the majority of other weeks in the summer, numbers of deaths registered were below the seasonal average. On average, 34 per cent of deaths registered each week during July and August occurred in those aged 75–84 and 31 per cent in those aged 85 and over. These proportions did not vary according to the temperatures recorded in each week, including week ending 15 August, and thus there is no evidence of a differential impact on older age groups.
	To support National Health Service managers in anticipating circumstances of weather related high demand, the Department of Health, together with the Meteorologicial Office, ran a weather forecast/health demand trial project, Forecasting the Nation's Health, supported by Treasury "Invest to Save" funding, over the winter of 2001–02 and 2002–03. It used weather forecasts and research data to provide NHS managers with advance warning of the impacts of weather and other key factors on health, and therefore hospital workloads, in their area. This alerted them as to when and where to expect increased emergency admissions and allows them to plan the use of resources more efficiently. Originally, the project was developed to look at winter weather events but this summer it has been successfully adapted to forecast the hot weather and issue advance warnings to hospitals participating in the pilot project and the public. In particular, a press release "Ten tips for surviving summer sun", providing advice on preventative measures was made by the department acting on advice from the Met Office on 5 August, in advance of the extreme temperatures—with particular emphasis on advice for the old and vulnerable.
	This work is without precedent internationally. The trial project has been completed and there are two external evaluations to look at the reliability and value of such workload forecasting for the NHS, following which the department will consider future development in this area.

Employment Law

Baroness Blatch: asked Her Majesty's Government:
	Whether the refusal by a professional to become involved with the placement of children for adoption by same-sex couples on the grounds of conscience is grounds for dismissal.

Lord Sainsbury of Turville: Employees who believe that they have been dismissed unfairly can complain to an employment tribunal, generally subject to a qualifying period of service. From 2 December 2003 it will be unlawful for an employer to discriminate against an employee on grounds of the employee's religion or belief. It is for the tribunals to decide whether any particular dismissal is fair or unfair in the light of all the circumstances and whether discrimination has occurred.

Employment Law

Baroness Blatch: asked Her Majesty's Government:
	What protection there is for a professional who for reasons of conscience is unable to agree to placing children for adoption with same-sex couples.

Lord Sainsbury of Turville: Employees who believe that they have been dismissed unfairly can complain to an employment tribunal, generally subject to a qualifying period of service. From 2 December 2003 it will be unlawful for an employer to discriminate against an employee on grounds of the employee's religion or belief. It is for the tribunals to decide whether any particular dismissal is fair or unfair in the light of all the circumstances and whether discrimination has occurred.

Consumer Law: Faulty Goods and Guarantees

Lord Morris of Manchester: asked Her Majesty's Government:
	What legal restraints apply to the failure by manufacturers to undertake repairs to or replacement of household refrigerators that break down within the guarantee period, when such breakdowns have health and other consequences for children, vulnerable elderly people or others in special need.

Lord Sainsbury of Turville: Current consumer law places the onus of responsibility for faulty goods primarily with the seller rather than the manufacturer. The law requires that goods must be fit for purpose and of satisfactory quality and if they are not, the consumer can request a full refund of their money within a reasonable time. Furthermore, for up to six years after purchase consumers can demand damages, or a repair or replacement. Any guarantee given by the manufacturer after 31 March is legally binding and can be enforced through the courts.

Sand Eels

The Duke of Montrose: asked Her Majesty's Government:
	When they expect the findings of the research on the effect of fishing for sand eels, currently being carried out for the Department for Environment, Food and Rural Affairs by a boat based at Grimsby, to be made public.

Lord Whitty: The two voyages by the vessel referred to were carried out under the fisheries science partnership between CEFAS and the NFFO. The findings will be made public once analysis has been completed and considered jointly by both members of the partnership.

Parliamentary Commissioner for Administration

Lord Lester of Herne Hill: asked Her Majesty's Government:
	Whether their response to the Public Administration Select Committee's Third Report of Session 2002–03 Ombudsman Issues (HC 448) means that they have decided not to introduce legislation to create a public right of direct access to the Parliamentary Commissioner for Administration; and, if not, what are their current intentions.

Lord Bassam of Brighton: The Government's position on legislation is set out in its response to the Public Administration Select Committee's report, Ombudsman Issues (HC 448). The issue of direct access to the Parliamentary Commissioner for Administration will form part of the work referred to in the Government's response.

Civil Service: Departmental Openness Contacts

Lord Lester of Herne Hill: asked Her Majesty's Government:
	Whether they will publish a list of lead contacts and departmental openness officers in the departments referred to in paragraph (c) of their response to the Public Administration Select Committee's Third Report of Session 2002–03, Ombudsman Issues (HC 448).

Lord Bassam of Brighton: Details of departmental openness contacts are already published in the Civil Service Yearbook. They are also published as an appendix to the Monitoring Report on the Code of Practice on Access to Government Information, published annually. Copies of these documents are available in the Libraries of the House.
	As the Government response to the Select Committee indicates, the Cabinet Office is currently compiling a list of departmental contacts tasked with ensuring that the ombudsman receives prompt responses to requests for information. This list will be of use primarily to the ombudsman and her staff, but I shall send a copy to the noble Lord when it is ready.

Channel Tunnel Rail Link

Lord Berkeley: asked Her Majesty's Government:
	What provision is planned for passengers to move the 400 metres between London Stratford international and domestic stations.

Lord Davies of Oldham: A number of options are under consideration between Union Railways (North), the designers of section 2 of the Channel Tunnel rail link, Chelsfield/Stanhope, the promoters of the Stratford City development and the London Borough of Newham, the local planning authority. A decision on the most appropriate form for the link has not yet been taken.

Channel Tunnel Rail Link

Lord Berkeley: asked Her Majesty's Government:
	Whether it is intended to move Eurostar's maintenance and servicing facility from North Pole to Temple Mills in London.

Lord Davies of Oldham: Operation of the Eurostar service following completion of section 2 of the Channel Tunnel rail link will require some form of maintenance and servicing facility at Temple Mills. My department is discussing with London & Continental Railways, the promoters of the Channel Tunnel rail link, what facilities should be provided at Temple Mills, and the implications for the present Eurostar facility at North Pole. No decisions have yet been taken.